Manufacturing Technician - Biosurgery

Location
US-MD-Columbia

Job ID

2018-1261

# Openings

3

Category

BioSurgery- Manufacturing Operations

Primary Purpose of Position

Responsible for hands-on execution of all activities in the Biosurgery manufacturing area, which encompasses the processing and packaging of tissue products for transplantation and for use in surgical procedures. All duties are performed in compliance with GMP/GTP, American Association of Tissue Banks Standards, and Osiris Standard Operating Procedures (SOPs). The candidate should have a commitment to high standards of quality.

Principal Responsibilities

Follow batch production records (BPRs) and SOPs for GMP/GTP manufacture of tissue products.

Utilize good documentation practices.

Assist in the preparation of reports and other documentation as applicable to the scope of operations in the manufacturing facility.

Identify areas for improvement in manufacturing efficiencies and compliance.

Assist with technology transfer from R&D to manufacturing environment.

Prepare (autoclave) equipment for use in cleanroom environment. Maintain working inventories of supplies within the production area.

Coordinate sample testing with QC.

Become an expert in selected key areas of interest.

Qualifications

MINIMUM QUALIFICATIONS:

Associate’s degree in a relevant scientific discipline and 3-4 years of relevant manufacturing experience in FDA regulated, controlled production environment

Or

Bachelor’s degree in a scientific discipline and 1-2 years of relevant manufacturing experience in a FDA regulated, controlled production environment.

Skill with aseptic technique.

Manual dexterity and attention to detail are required.

Technical accuracy and ability to perform mathematical calculations.

Strong interpersonal skills and the ability to work effectively and efficiently in a team environment.

Excellent oral and written communication skills.

Ability to work flexible hours, including possible overtime and weekends.

Experience with aseptic technique and working in class 100 and 10,000 controlled environments (cleanroom).

Knowledge of GTPs, GMPs and other applicable standards.

Skilled with good documentation practices.

Osiris Therapeutics, Inc. is an Equal Opportunity Employer with a commitment to diversity. Applicants are considered on the basis of individual merit without regard to race, color, national or ethnic origin, gender, gender identity, sexual orientation, marital status, veteran status, pregnancy, age, religion, disability, genetic information, or any other characteristic protected by law